Your ready-to-use quality management system. Simplified.
QFacts is an easy-to-use, complete eQMS for regulated companies. Our automated workflows embrace the essence of a lean and compliant process.
Built on a certified security foundation
QFacts is independently certified and audited, so your quality data stays secure and your compliance documentation is always audit-ready.
QFacts is certified
ISO 27001 Certified
Independently certified via Secfix with 90 security controls across organizational, technological, physical, and personnel security.
GAMP 5 Validated
Platform validation follows GAMP 5 guidelines, the gold standard for computerized system validation in regulated pharma and life sciences.
Built to support your compliance with
Intuitive Quality Management
QFacts offers an intuitive, ready-to-use, and compliant solution to manage all your quality processes electronically in the cloud. Our software is fully validated according to GAMP 5 guidelines ensuring global regulatory compliance for pharmaceutical and biotech companies. Developed by Quality Managers who understand your challenges. Sign up in just one click!
Document Management
Store, create, review, and approve all your documents in a secure, centralized repository. Track version history and maintain compliance easily, all while keeping your team on the same page - literally.
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Training
Quick setup of document-based, classroom, and on-the-job training with automatic assignments based on configurable training curricula. Say goodbye to your paper training system and hello to easy tracking of employee qualifications.
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Events & Complaints
Simplify the reporting of any quality-related events and complaints. Notify your Quality team instantly, assess impact, and escalate to a full investigation record if required.
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Investigations
Perform detailed root cause investigations and report your findings to the quality team. Direct integration with the CAPA & action modules.
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CAPAs
Set up CAPA plans with clear actions, owners, and due dates. Ensure accountability and enable efficacy checks to prevent recurrence of issues with minimal hassle.
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Change Control
Manage your change control process with ease. Document, review, and approve changes while maintaining full regulatory compliance. From minor updates to major process changes, ensure every step is logged and traceable.
Discover moreEasy onboarding. Flexible user roles.
Organisation Admin
Admins can easily manage user access and record settings.
Action Owner
Action Owners can create, edit, review, and assess all types of records.
QA
QA users can perform impact assessments and provide closure approvals.
Operator
Operators can access documents & complete training assignments.
Designed by Quality professionals. Engineered for excellence.
Unlike many other systems that are developed by IT professionals chasing a business opportunity, QFacts is designed by experienced Quality professionals, people who truly understand the challenges of QA teams.
Many eQMS solutions come with excessive costs or rigid, inefficient workflows that require companies to adapt their processes to the system. QFacts takes a different approach. We’ve designed a system that works the way you want it to - efficient, compliant, easy to implement, and cost-effective.
We created QFacts because we experienced the challenges for small and mid-sized companies in regulated ecosystems ourselves. The market lacked a leading eQMS that was both efficient and affordable. We were determined to build a solution that stands out - one that truly meets the needs of growing companies without the high costs or unnecessary complexity. That’s how QFacts was born.
Why QFacts?
Lean
Built based on our own experience in the sector, we drilled down all quality processes to the essence of a lean and compliant workflow according to industry best practices.
Plug-and-play
Easy onboarding on a fully validated platform. No lengthy or complex system implementation required. We simplify your QMS without compromising compliance!
Scalable
No excessive or vague cost structures. A transparent and fair pricing model - affordable for small and mid-sized companies.
Get in touch
Contact us for a personalised demo or to learn more about how QFacts can help your team.